Florida Administrative Code
59 - AGENCY FOR HEALTH CARE ADMINISTRATION
59C - Certificate of Need
Chapter 59C-1 - PROCEDURES FOR THE ADMINISTRATION OF SECTIONS 408.031-408.045, FLORIDA STATUTES, HEALTH FACILITY AND SERVICES DEVELOPMENT ACT
Section 59C-1.044 - Organ Transplantation
Universal Citation: FL Admin Code R 59C-1.044
Current through Reg. 50, No. 187; September 24, 2024
(1) Agency Intent. This rule implements the provision of Section 408.036(1)(f), F.S., which requires the Agency to review the establishment of organ transplantation programs under the Certificate of Need program which shall include heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestines. Applications for organ transplantation programs shall be reviewed against the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule. This rule defines the minimum requirements for personnel, equipment, and support services for organ transplantation programs. In addition, the rule includes a need methodology for the establishment of organ transplantation programs by type. An applicant shall apply for each type of organ transplantation program. A separate Certificate of Need is required for pediatric organ transplant programs by type. Applicants for each type of transplantation program shall meet the requirements specified in subsections (3), (4) and (5). Additional requirements for heart transplantation programs are specified in subsection (6); for liver transplantation programs in subsection (7); for kidney transplantation programs in subsection (8); for allogeneic and autologous bone marrow transplantation programs in subsection (9); and for lung, heart and lung, pancreas and islet cells, and intestines transplants, in subsection (10). The following organ transplantation programs shall be restricted to teaching or research hospitals: liver, adult allogeneic bone marrow, pediatric allogeneic and autologous bone marrow, lung, heart and lung, pancreas and islet cells, and intestines.
(2) Definitions.
(a) Bone Marrow Transplantation. Human blood
precursor cells, stem cells, administered to a patient to restore normal
hematological and immunological functions following ablative or nonablative
therapy with curative or life-prolonging intent. Human blood precursor cells
may be obtained from the patient in an autologous transplant or from a
medically acceptable related or unrelated donor, and may be derived from bone
marrow, circulating blood, or a combination of bone marrow and circulating
blood. If chemotherapy is an integral part of the treatment involving bone
marrow transplantation, the term "bone marrow transplantation" includes both
the transplantation and the chemotherapy. (Section
627.4236(1),
F.S.).
(b) Organs. Organs as used
in this rule include heart, kidney, liver, bone marrow, lung, heart and lung,
pancreas and islet cells, and intestines.
(c) Pediatric Patient. A patient under the
age of 15 years.
(d) Research
Hospital. A hospital which devotes clearly defined space, staff, equipment, and
other resources for research purposes, and has documented teaching affiliations
with an accredited school of medicine in Florida or another state.
(e) Research Program. An organized program
that conducts clinical trial research, collects treatment data, assesses
outcome data, and publishes statistical reports showing research activity and
findings.
(f) Service Planning
Area. Planning for organ transplantation programs shall be done on a
regionalized basis. Certificate of Need applications shall be competitively
reviewed within each of the four service planning areas delineated below:
1. Service planning area one includes
District 1, District 2, District 3 excluding Lake County, and District 4
excluding Volusia County;
2.
Service planning area two includes District 5, District 6, and District 8
excluding Collier County;
3.
Service planning area three includes District 7, District 9 excluding Palm
Beach County, and includes Lake and Volusia Counties; and,
4. Service planning area four includes
District 10, District 11, and Collier and Palm Beach
Counties.
(g) Teaching
Hospital. Any hospital which meets the conditions specified in Section
408.07(45),
F.S.
(h) Transplantation Program.
The offering of surgical services by a hospital through which one or more types
of organ transplants are provided to one or more patients; and the offering of
some or all phases of bone marrow transplantation.
(3) Coordination of Services. Applicants for transplantation programs, regardless of the type of transplantation program, shall have:
(a) Staff and other resources
necessary to care for the patient's chronic illness prior to transplantation,
during transplantation, and in the post-operative period. Services and
facilities for inpatient and outpatient care shall be available on a 24-hour
basis.
(b) If cadaveric
transplantation will be part of the transplantation program, a written
agreement with an organ acquisition center for organ procurement is required. A
system by which 24-hour call can be maintained for assessment, management and
retrieval of all referred donors, cadaver donors or organs shared by other
transplant or organ procurement agencies is mandatory. Applicants for a bone
marrow transplantation program are exempt from this requirement.
(c) An age-appropriate (adult or pediatric)
intensive care unit which includes facilities for prolonged reverse isolation
when required.
(d) A clinical
review committee for evaluation and decision-making regarding the suitability
of a transplant candidate.
(e)
Written protocols for patient care for each type of organ transplantation
program including, at a minimum, patient selection criteria for patient
management and evaluation during the pre-hospital, in-hospital, and immediate
post-discharge phases of the program.
(f) Detailed therapeutic and evaluative
procedures for the acute and long term management of each transplant program
patient, including the management of commonly encountered
complications.
(g) Equipment for
cooling, flushing, and transporting organs. If cadaveric transplants are
performed, equipment for organ preservation through mechanical perfusion is
necessary. Applicants for a bone marrow transplantation program are exempt from
this requirement. This requirement may be met through an agreement with an
organ procurement Agency.
(h) An
onsite tissue-typing laboratory or a contractual arrangement with an outside
laboratory within the State of Florida, which meets the requirements of the
American Society of Histocompatibility.
(i) Pathology services with the capability of
studying and promptly reporting the patient's response to the organ
transplantation surgery, and analyzing appropriate biopsy material.
(j) Blood banking facilities.
(k) A program for the education and training
of staff regarding the special care of transplantation patients.
(l) Education programs for patients, their
families and the patient's primary care physician regarding after-care for
transplantation patients.
(4) Staffing Requirements. Applicants for transplantation programs, regardless of the type of transplantation program, shall meet the following staffing requirements:
(a) A staff of physicians with expertise in
caring for patients with end-stage disease requiring transplantation. The staff
shall have medical specialties or sub-specialties appropriate for the type of
transplantation program to be established. The program shall employ a
transplant physician, and a transplant surgeon, if applicable, as defined by
the United Network for Organ Sharing (UNOS) June 1994. The UNOS definitions are
incorporated herein by reference. A physician with one year experience in the
management of infectious diseases in the transplant patient shall be a member
of the transplant team;
(b) A
program director who shall have a minimum of 1 year of formal training and 1
year of experience at a transplantation program for the same type of organ
transplantation program proposed. Provided, however, that an applicant for a
bone marrow transplantation program shall meet the requirements in subsection
(9);
(c) A staff with experience in
the special needs of children if pediatric transplantations are
performed;
(d) A staff of nurses,
and nurse practitioners with experience in the care of chronically ill patients
and their families;
(e) Contractual
agreements with consultants who have expertise in blood banking and are capable
of meeting the unique needs of transplant patients on a long term
basis;
(f) Nutritionists with
expertise in the nutritional needs of transplant patients;
(g) Respiratory therapists with expertise in
the needs of transplant patients; and,
(h) Social workers, psychologists,
psychiatrists, and other individuals skilled in performing comprehensive
psychological assessments, counselling patients, and families of patients,
providing assistance with financial arrangements, and making arrangements for
use of community resources.
(5) Data Reporting Requirements. Facilities with organ transplantation programs shall submit data regarding each transplantation program to the Agency or its designee, within 45 days after the end of each calendar quarter, facilities with organ transplantation programs, shall report to the Agency, or its designee, the total number of transplants by organ type which occurred in each month of the quarter.
(6) Heart Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for a heart transplantation program shall not normally be approved in a service planning area unless the following additional criteria are met.
(a) Staffing Requirements. An applicant for a
heart transplantation program shall have the following program personnel and
services:
1. A board-certified or board
eligible adult cardiologist; or, in the case of a pediatric heart
transplantation program, a board-certified or board eligible pediatric
cardiologist;
2. An
anesthesiologist experienced in both open heart surgery and heart
transplantation; and,
3. A one bed
isolation room in an age-appropriate intensive care unit.
(b) Need Determination. An application for a
Certificate of Need to establish a heart transplantation program shall not
normally be approved in a service area unless:
1. Each existing heart transplantation
provider in the applicable service area performed a minimum of 24 heart
transplants in the most recent calendar year preceding the application deadline
for new programs, and no other heart transplantation program has been approved
for the same service planning area;
2. The application contains documentation
that a minimum of 12 heart transplants per year will be performed within 2
years of Certificate of Need approval. Such documentation shall include, at a
minimum, the number of hearts procured by Florida hospitals during the most
recent calendar year, and an estimate of the number of patients in the service
planning area who would meet commonly-accepted criteria identifying potential
heart transplant recipients;
3. The
application includes documentation that the annual duplicated cardiac
catheterization patient caseload was at or exceeded 500 for the calendar year
preceding the Certificate of Need application deadline; and that the duplicated
patient caseload for open heart surgery was at or exceeded 150 for the calendar
year preceding the Certificate of Need application deadline; and,
4. An application for a pediatric heart
transplantation program shall include documentation that the annual duplicated
cardiac catheterization patient caseload was at or exceeded 200 for the
calendar year preceding the Certificate of Need application deadline; and that
the duplicated cardiac open heart surgery caseload was at or exceeded 125 for
the calendar year preceding the Certificate of Need application
deadline.
(7) Liver Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for a liver transplantation program shall not normally be approved unless the following additional criteria are met:
(a) An applicant
for a Certificate of Need to establish a liver transplantation program must be
a teaching hospital or research hospital with training programs relevant to
liver transplantation.
(b)
Coordination of Services. The following services shall be available in the
hospital, or through contractual arrangements:
1. A department of gastroenterology,
including clinics, and adequately equipped procedure rooms;
2. Radiology services to provide complex
biliary procedures, including transhepathic cholangiography, protal venography
and arteriography;
3. A laboratory
with the capability of performing and promptly reporting the results of liver
function tests as well as required chemistry, hematology, and virology tests;
and,
4. A patient convalescent unit
for further monitoring of patient progress for approximately one month
post-hospital discharge following liver transplantation.
(c) Staffing Requirements. In addition to the
general staffing requirements for all transplantation programs, program staff
for liver transplantation programs shall be trained in the care of patients
with hepatic diseases, and liver transplantation.
(d) Need Determination.
1. The application includes documentation
that a minimum of five liver transplants will be performed within 2 years of
Certificate of Need approval. Such evidence shall include, at a minimum, the
number of livers procured in the state during the most recent calendar year,
and an estimate of the number of patients in the service delivery area who
would meet commonly-accepted criteria identifying potential liver transplant
recipients. The caseload estimate shall be based on the number of persons with
end-stage hepatic diseases in the service planning area, for which death due to
the disease is likely to occur within 1 year without the
transplantation.
2. The application
includes documentation that the new liver transplantation program improves
patient access.
(8) Kidney Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), a Certificate of Need for a new kidney transplantation program shall not normally be approved unless the following additional criteria are met:
(a) Coordination of Services.
1. Inpatient services shall be available
which shall include renal dialysis, and pre- and post operative care. There
shall be 24-hour availability of onsite dialysis under the supervision of a
board-certified or board eligible nephrologist. If pediatric patients are
served, a separate pediatric dialysis unit shall be established.
2. Outpatient services shall be available
which shall include renal dialysis services and ambulatory renal clinic
services.
3. Ancillary services
shall include pre-dialysis, dialysis, and post transplantation nutritional
services; bacteriologic, biochemical, and pathological services; radiologic
services; and nursing services with the capability of monitoring and support
during dialysis and assisting in home care including vascular access, and home
dialysis management, when applicable.
(b) Staffing Requirements for Adult Kidney
Transplantation Programs.
1. The kidney
transplantation program shall be under the direction of a physician with
experience in physiology, immunology and immuno-suppressive therapy relevant to
kidney transplantation.
2. The
transplant surgeon shall be board-certified in surgery or a surgical
subspecialty, and shall have a minimum of 18 months training in a transplant
center.
3. The transplant team
performing kidney transplantation shall include physicians who are
board-certified or board-eligible in the areas of Anesthesiology, Nephrology,
Psychiatry, Vascular Surgery, and Urology.
4. Additional support personnel which shall
be available include a nephrology nurse with experience in nursing care of
patients with permanent kidney failure, and a renal dietician.
5. A laboratory with the capability of
performing and promptly reporting bacteriologic, biochemical and pathologic
analysis.
6. An anesthesiologist
experienced in kidney transplantation.
(c) Staffing Requirements for Pediatric
Kidney Transplantation Programs. Applicants for a kidney transplantation
program which will serve pediatric patients shall have the following staffing:
1. A medical director who is
sub-board-certified or sub-board-eligible in pediatric nephrology.
2. A dialysis unit head nurse with special
training and expertise in pediatric dialysis.
3. Nurse staffing at a nurse to patient ratio
of 1 to 1 in the pediatric dialysis unit.
4. A registered dietician with expertise in
nutritional needs of children with chronic renal disease.
5. A surgeon with experience in pediatric
renal transplantation.
6. A
radiology service with specialized equipment for obtaining x-rays on pediatric
patients.
7. Education services to
include home and hospital programs to ensure minimal interruption in school
education.
(d) Need
Determination. Applications for the establishment of new kidney transplantation
programs shall not normally be approved unless the following need criteria are
met:
1. Each existing kidney transplantation
provider in the applicable service area performed a minimum of 30 kidney
transplants in the most recent calendar year preceding the application
deadline, and no additional program has been approved for the same service
planning area;
2. If pediatric
kidney transplants will be performed, each existing pediatric kidney transplant
program performed a minimum of 10 pediatric kidney transplants during the
calendar year preceding the application deadline, and no additional program has
been approved for the same service planning area;
3. The application shall include
documentation that a minimum of fifteen kidney transplants per year will be
performed within 2 years of program operation. Such documentation shall
include, at a minimum, the number of kidneys procured in the state during the
most recent calendar year, and an estimate of the number of patients who would
meet commonly-accepted criteria identifying potential kidney transplant
recipients. This estimate shall be based on the number of patients on dialysis
within the same service planning area; and,
4. If pediatric kidney transplants will be
performed, the application shall include documentation that a minimum of 5
pediatric kidney transplants per year will be performed within two years of
Certificate of Need approval.
(9) Allogeneic and Autologous Bone Marrow Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for new bone marrow programs shall not normally be approved unless the following additional requirements and criteria are met.
(a) Pediatric Allogeneic and
Autologous Bone Marrow Transplantation Programs. Pediatric allogeneic and
autologous bone marrow transplantation programs shall be limited to teaching
and research hospitals with training programs relevant to pediatric bone marrow
transplantation. All applicants shall meet the requirements specified in
subparagraph 1., below. Applicants for allogeneic programs shall meet the
additional requirements specified in subparagraph 2., below:
1. Requirements for Pediatric Allogeneic and
Autologous Transplantation Programs;
a.
Applicants shall be able to project that at least 10 pediatric transplants will
be performed each year. If both allogeneic and autologous pediatric transplants
are performed, at least 10 of each shall be projected. New units shall be able
to project the minimum volume for the third year of operation;
b. A program director who is a board
certified hematologist or oncologist with experience in the treatment and
management of pediatric acute oncological cases involving high dose
chemotherapy or high dose radiation therapy. The program director must have
formal training in pediatric bone marrow transplantation;
c. Clinical nurses with experience in the
care of critically ill immuno-suppressed patients. Nursing staff shall be
dedicated full time to the program;
d. An interdisciplinary transplantation team
with expertise in hematology, oncology, immunologic diseases, neoplastic
diseases, including hematopoietic and lymphopoietic malignancies, and
non-neoplastic disorders. The team shall direct permanent follow-up care of the
bone marrow transplantation patients, including the maintenance of
immunosuppressive therapy and treatment of complications;
e. Age appropriate inpatient transplantation
units for post-transplant hospitalization. Post-transplantation care must be
provided in a laminar air flow room; or in a private room with positive
pressure, reverse isolation procedures, and terminal high efficiency
particulate aerosol filtration on air blowers. The designated transplant unit
shall have a minimum of 2 beds. This unit can be part of a facility that also
manages patients with leukemia or similar disorders;
f. A radiation therapy division onsite which
is capable of sub-lethal x-irradiation, bone marrow ablation, and total
lymphoid irradiation. The division shall be under the direction of a board
certified radiation oncologist;
g.
An ongoing research program that is integrated either within the hospital or by
written agreement with a bone marrow transplantation center operated by a
teaching hospital. The program must include outcome monitoring and long-term
patient follow-up; and;
h. An
established research-oriented oncology program.
2. Additional Requirements for Pediatric
Allogeneic Transplantation Programs:
a. A
laboratory equipped to handle studies including the use of monoclonal
antibodies, if this procedure is employed by the hospital, or T-cell depletion,
separation of lymphocyte and hematological cell subpopulations and their
removal for prevention of graft versus host disease. This requirement may be
met through contractual arrangements;
b. An onsite laboratory equipped for the
evaluation and cryopreservation of bone marrow;
c. An age appropriate patient convalescent
facility to provide a temporary residence setting for transplant patients
during the prolonged convalescence; and,
d. An age appropriate outpatient unit for
close supervision of discharged patients.
(b) Adult Allogeneic Bone Marrow
Transplantation Programs. Adult allogeneic bone marrow transplantation programs
shall be limited to teaching and research hospitals. Applicants shall meet the
following requirements:
1. Applicants shall be
able to project that at least 10 adult allogeneic transplants will be performed
each year. New units shall be able to project the minimum volume for the third
year of operation;
2. A program
director who is a board certified hematologist or oncologist with experience in
the treatment and management of adult acute oncological cases involving high
dose chemotherapy or high dose radiation therapy. The program director must
have formal training in bone marrow transplantation;
3. Clinical nurses with experience in the
care of critically ill immuno-suppressed patients. Nursing staff shall be
dedicated full time to the program;
4. An interdisciplinary transplantation team
with expertise in hematology, oncology, immunologic diseases, neoplastic
diseases, including hematopoietic and lymphopoietic malignancies, and
non-neoplastic disorders. The team shall direct permanent follow-up care of the
bone marrow transplantation patients, including the maintenance of
immunosuppressive therapy and treatment of complications;
5. Inpatient transplantation units for
post-transplant hospitalization. Post-transplantation care must be provided in
a laminar air flow room; or in a private room with positive pressure, reverse
isolation procedures, and terminal high efficiency particulate aerosol
filtration on air blowers. The designated transplant unit shall have a minimum
of 2 beds. This unit can be part of a facility that also manages patients with
leukemia or similar disorders;
6. A
radiation therapy division onsite which is capable of sub-lethal x-irradiation,
bone marrow ablation, and total lymphoid irradiation. The division shall be
under the direction of a board certified radiation oncologist;
7. A laboratory equipped to handle studies
including the use of monoclonal antibodies, if this procedure is employed by
the hospital, or T-cell depletion, separation of lymphocyte and hematological
cell subpopulations and their removal for prevention of graft versus host
disease. This requirement may be met through contractual
arrangements;
8. An onsite
laboratory equipped for the evaluation and cryopreservation of bone
marrow;
9. An ongoing research
program that is integrated either within the hospital or by written agreement
with a bone marrow transplantation center operated by a teaching hospital. The
program must include outcome monitoring and long-term patient
follow-up;
10. An established
research-oriented oncology program;
11. A patient convalescent facility to
provide a temporary residence setting for transplant patients during the
prolonged convalescence; and,
12.
An outpatient unit for close supervision of discharged
patients.
(c) Adult
Autologous Bone Marrow Transplantation Programs. Adult autologous bone marrow
transplantation programs can be established at teaching hospitals or research
hospitals; or at community hospitals having a research program, or who are
affiliated with a research program, as defined in this rule. Applicants shall
meet the following requirements:
1. Applicants
shall be able to project that at least 10 adult autologous transplants will be
performed each year. New units shall be able to project the minimum volume for
the third year of operation;
2. A
program director who is a board certified or board eligible hematologist or
oncologist with experience in the treatment and management of adult acute
oncological cases involving high dose chemotherapy or high dose radiation
therapy. The program director must have formal training in bone marrow
transplantation, or have at least 1 year of documented experience in performing
autologous bone marrow transplantation;
3. Clinical nurses with experience in the
care of critically ill immuno-suppressed patients. Nursing staff shall be
dedicated full time to the program;
4. An interdisciplinary transplantation team
with expertise in hematology, oncology, immunologic diseases, neoplastic
diseases, including hematopoietic and lymphopoietic malignancies, and
non-neoplastic disorders. The team shall direct permanent follow-up care of the
bone marrow transplantation patients;
5. Inpatient transplantation units for
post-transplant hospitalization. Post-transplantation care must be provided in
a laminar air flow room; or in a private room with positive pressure, reverse
isolation procedures, and terminal high efficiency particulate aerosol
filtration on air blowers. The designated transplant unit shall have a minimum
of 2 beds. This unit can be part of a facility that also manages patients with
leukemia or similar disorders;
6. A
radiation therapy division onsite which is capable of sub-lethal x-irradiation
and total lymphoid irradiation. The division shall be under the direction of a
board certified radiation oncologist;
7. An ongoing research program that is
integrated either within the hospital or by written agreement with a bone
marrow transplantation center operated by a teaching hospital; or the applicant
may enter into an agreement with an outpatient provider having a research
program, as defined in this rule. Under the agreement, the outpatient research
program may perform specified outpatient phases of adult autologous bone marrow
transplantation, including blood screening tests, mobilization of stem cells,
stem cell rescue, chemotherapy, and reinfusion of stem cells; and,
8. An established research-oriented oncology
program.
(d)
Grandfathering Provisions for Hospitals Without Certificate of Need Approval.
Hospitals that prior to March 1, 1993, operated a bone marrow transplantation
program, as defined in this rule, without Certificate of Need approval, shall
provide written documentation to the Agency that they meet the applicable
requirements of subsections (3), (4) and (9) of this rule. Hospitals that meet
the requirements shall be authorized to continue to provide the
service.
(10) Transplantation Programs for Lung, Heart and Lung, Pancreas and Islet Cells, and Intestines. In addition to meeting the requirements specified in subsections (3), (4) and (5), Certificate of Need applications for the establishment of new transplantation programs involving lung, heart and lung, pancreas and islet cells or intestines shall not normally be approved unless the following additional criteria are met:
(a)
The applicant is a teaching or research hospital with training programs
relevant to the type of organ transplantation program proposed to be
established; and,
(b) Applicants
have established interactive programs of basic and applied research in organ
failure, transplantation, immunoregulatory responses, and related
biology.
(11) Pediatric transplant programs with a valid CON at a Medicaid designated transplant center may perform transplants for patients under the age of 21. In case of conflict between provisions in this rule, the provisions of this subsection shall prevail.
Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(f), 408.032(17), 408.033(1)(b)4., 11. FS.
New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(x), 10-5.044, Amended 8-24-93, 12-13-94, 7-6-09, 4-18-18.
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